Kornimate/medical-research-clean huggingface dataset:
role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract

Conditions: HIV/AIDS; Menopause; Inflammation Vagina

Summary: cervical biopsies will be collected from women aged 18 and over whom are virally suppressed and taking tenofovir as part of their antiretroviral therapy regimen. blood plasma, peripheral blood mononuclear cells (pbmc), and cervicovaginal swabs will also be collected. drug concentrations, hormone concentrations, inflammatory cytokines, and vaginal microbiome will be evaluated to understand the role of hormones, inflammation, and the microbiome in modulating drug efficacy in the female genital tract.


Eligibility criteria:
inclusion criteria: 1. female, or transgender female with a cervix, age 18 years or older 2. hiv-positive 3. stable on antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks at time of enrollment. 4. virally suppressed (hiv-rna copies \<50 copies/ml) for at least 6 months at time of enrollment. 5. willing to refrain from vaginal intercourse and use of vaginal devices such as douches and sex toys within 72 hours of the biopsy visit. 6. willing and able to give signed informed consent.

Keywords: tenofovir prevention microbiome cervicovaginal biopsy swab cytokines inflammation pharmacology
new dual therapy for primary treatment of helicobacter pylori infection：a pilot study

Conditions: Functional Dyspepsia

Summary: the efficacy of traditional triple therapy has been decreased to such an unacceptable level as 70% in many areas. the study is based on the hypothesis: the most important factors which influence the effect of helicobacter pylori (h. pylori) eradication included acid suppression intensity and sensitivity of antibiotics. so the investigators chose dual therapy because it is simple and verified to be useful. rabeprazole, as a new proton pump inhibitor (ppi), is reported to be less susceptible to the influence of genetic polymorphisms for cyp2c19. so it has a greater and faster acid suppression effect compared to other ppis. amoxicillin is one of effective antibiotics to h. pylori with few side effects. the antibiotic resistance of amoxicillin is no more than 3% in china. the purpose of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens with different doses of rabeprazole for initial treatment of h. pylori infection.

the current recommended triple regimen for h. pylori treatment provides unacceptable low success rates because of high antibiotic resistance and poor compliance. dual therapy had been used before and can be modified to get good eradication rate. the aim of our trial is to evaluate and compare the efficacy and safety of dual therapy regimens for initial treatment of h. pylori infection. a total of forty patients with non-ulcer dyspepsia and h. pylori infection were randomized to receive either rabeprazole 10 mg b.i.d. and amoxicillin 1000 mg t.i.d., for 14 days (r10a), or high-dose rabeprazole 20 mg twice a day (b.i.d.) and amoxicillin 1000 mg three times a day (t.i.d) (r20a) for 14 days. h. pylori strains were isolated and antibiotic resistance was measured by the twofold agar dilution method. h. pylori eradication was assessed by 13c-urea breath test at 4 weeks after treatment.

Eligibility criteria:
inclusion criteria: patients aged from 18 to 70 years, who presented with upper gastrointestinal symptoms and endoscopically proven h. pylori-positive non-ulcer dyspepsia, were recruited into the study. exclusion criteria: * patients with peptic ulcer, * previous h. pylori eradication treatment, * previous gastric surgery, * pregnancy, * lactation, * major systemic diseases, * receipt of anti-secretory therapy, * antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.

Keywords: h. pylori dual therapy amoxicillin rabeprazole
beta cell function in (pre) type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.

this study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes. these criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints. this may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.

Eligibility criteria:
inclusion criteria: * the following groups of first degree relatives of type1 diabetes patients with normal glucose tolerance during ogtt (5-39 years) will be included after informed consent on the basis of their antibody status (n = 40 per group): * ia-2a-positives; * ab.-positives (positive for at least 2 different abs. (iaa, gada and/or ica) and/or persistently ab.-positive for 1 of these abs; * persistently ab.-negatives. * 40 type 1 diabetes patients with the following criteria will be studied: 1) aged 12-39 years; 2) \< 4 weeks of insulin treatment; 3) auto-ab.-positive; 4) polyuria since \< 6 months; 5) \< 10% weight loss over the last 6 months; 6) informed consent. exclusion criteria: * pregnancy or lactation in women * use of illicit drugs or overconsumption of alcohol (\> 3 beers/day) or history of drug or alcohol abuse * being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders * having received antidepressant medications during the last 6 months * treatment with immune modulating or diabetogenic medication (such as corticosteroids) * presently participating in another clinical study * history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects

Keywords: first degree relatives of type 1 diabetes patients hyperglycemic clamp test
contractile reserve in dyssynchrony: a novel principle to identify candidates for cardiac resynchronization therapy

Conditions: Heart Failure; Cardiomyopathy

Summary: cardiac resynchronisation therapy (crt) has been documented to be a powerful treatment in patients with severe congestive heart failure. however, 30-40% of patients receiving a crt are non-responders. in this study the investigators will use a previously validated method to estimate myocardial segment work non-invasively by speckle-tracking echocardiography and blood pressure. furthermore, cardiac magnetic resonance imaging (cmr) with late gadolinium enhancement (lge) will be performed in feasible subjects. the main purpose of the study is to determine if myocardial work by echocardiography in combination with viability assessment by lge-cmr can predict response to crt.


Eligibility criteria:
inclusion criteria: * subject is indicated for crt device according to european society of cardiology (esc) guidelines from 2013. * subject is willing to sign informed consent form and is 18 years or older. exclusion criteria: * right bundle branch block. * recent myocardial infarction, within 40 days prior to enrollment. * subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days. * post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year * implanted with a lv assist device (lvad), or has reasonable probability (per investigator's discretion) of receiving a lvad in the next year * severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period). * complex and uncorrected congenital heart disease. * breastfeeding women or women of child bearing potential. * enrolled in one or more concurrent studies that would confound the results of this study. * impossible to obtain lv volumes by echocardiography
sexual dysfunction in hypertensive women

Conditions: Hypertension

Summary: several studies describe the existence of an association between sexual dysfunction and high blood pressure (hypertension), most often characterized by a decrease in the number of orgasms and the existence of dyspareunia. hypertension is a contributing factor, and nonadherence to medication could amplify it. there are several ways to assess adherence to treatment: the use of declarative questionnaires, a method not without criticism because it is subject to the subjectivity of the declaration by the patient; and drug dosages, a standard technique, although insufficiently disseminated due to the high cost and greater weight of the survey protocols. drug non-compliance is multifactorial. in addition, it has been shown that having undesirable drug effects and / or being afraid of developing them is one of the major causes of non-compliance with antihypertensive treatments. the investigators hypothesize that ds is significantly more common among hypertensive women treated with non-observers compared to hypertensive women treated with observers. the main objective is to compare the prevalence of sexual dysfunction between a group of hypertensive women treated as observers and a group of hypertensive women treated as non-observers.


Eligibility criteria:
inclusion criteria: * women over 18, * hospitalized or received in consultation for the management of hypertension treated in one of the hypertension and therapeutic, nephrology or cardiology departments participating in the study, with confirmed hypertension, treated with the following dosable antihypertensive agent(s): diltiazem, verapamil, acebutolol, atenolol, nébivolol, bisoprolol, metoprolol, propranolol, amiloride, furosemide, hydrochlorothiazide, indapamide, spironolactone, spironolactone, lorsartan, irbesartan, ramipril, perindopril, amlodipine, * having signed the informed consent form. * beneficiary or affiliated to a french social insurance exclusion criteria: * patients with bariatric surgery, * patients under guardianship/trusteeship/protection of justice, * patients with diagnosed and treated psychosis or depression, - pregnant or nursing women.

Keywords: high blood pressure antihypertensive drugs sexual dysfunction
lung cancer diagnosis by detecting epigenetic imprinting alterations in bronchoalveolar lavage

Conditions: Lung Cancer

Summary: the goal of this multicenter observational study is to evaluate the lung cancer diagnostic value of epigenetic imprinting detection in bronchoalveolar lavage. this study will mainly focus on varifing the previously identified epigenetic imprinting biomarkers for lung cancer and upgrading and validating a lung cancer imprinting diagnostic model specifically for bronchoalveolar lavage. the lavage sample will be collected from each eligible paticipants under bronchialscopy and undergo qcigish detection to analyze the allelic expression status of imprinted genes. the qcigish detection results will be compared with the final surgical histopathology. no interventions will be taken according to the qcigish detection results.

bronchial biopsy and bursh are widely used in lung cancer diagnosis but not bronchoalveolar lavage because of its low sensitivity. as the molecular alterations usually occur before the morphological changes, genetic and epigenetic biomarkers will be helpful for early diagnosis of cancers. as an important epigenetic regulation in mammalian embryo development, genomic imprinting plays important roles in cancers. in normal post-natal somatic cells, imprinted genes are "silenced", that is mono-allelically expressed either from the maternal or paternal allele, while in cancers, some silenced imprinting genes' copies could be reactivated, leading to expressions from both alleles. the loss of monoallelic gene regulation is named loss of imprinting (loi), and has been previously found in various human cancers. our previous studies has identified several imprinted genes with elevated aberrant allelic expressions in lung cancer. a diagnostic model based on the epigenetic imprinting biomarkers achieved 99.1% sensitivity and 92.1% specificity. in this study, we will first verify the epigenetic imprinting biomarkers in bronchoalveolar lavage, and refine the previously developed diagnostic model specifically for lavage samples. the diagnostic model will be independently validated in a group of prospectively enrolled cases. this study will help to distinguish benign and malignant pulmonary nodules presurgically, and improve the early diagnosis of lung cancer.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, and ≤ 75 years old; * chest ct showed pulmonary nodule with diameter\<3cm; * subjects voluntarily participated and signed the informed consent form. exclusion criteria: * active massive hemoptysis; * severe heart and lung dysfunction; * severe arrhythmia; * extreme exhaustion of general condition; * coagulation dysfunction; * acute attack of asthma; * aortic aneurysm.

Keywords: genomic imprinting epigenetics diagnostic study bronchoalveolar lavage
clinical evaluation of a myopia control lens in slowing myopia progression (dal)

Conditions: Myopia

Summary: this is a mono-centre, prospective, one-arm, unmask clinical trial to evaluate the effectiveness of test lens in slowing myopia progression with respect to axial length elongation compared to a single vision spectacle lens from the historical control group of another clinical trial nct05331378. a total of 40 children will be recruited

as myopia is a growing worldwide problem, it is important to better understand the range of possible treatments to slow the progression of myopia. spectacle lenses with aspherical lenslets were shown to be effective in reducing myopia progression and axial length elongation in children in the previous clinical trial (bao et al. 2022). a dose-dependent effect was demonstrated, with higher lenslet asphericity having greater myopia control efficacy. this open clinical trial will test the safety and effectiveness of a test lens designed to modify the area and amount of myopic defocus on the retina without compromising vision. the study population includes children in singapore aged 8 to 13 years (40 subjects) at the time of commencing treatment. axial length and spherical equivalent refraction will be the primary measure for myopia progression. visual acuities will also be compared between test lenses and control lenses of the historical control group to determine the quality of vision using test lenses

Eligibility criteria:
inclusion criteria: * volunteer subject and guardian, fluent english spoken, willing to follow protocol and able to read, comprehend and sign the informed consent \& assent form. * 8 to 13 years old at time of informed consent and assent. * spherical equivalent refractive error (ser) by manifest refraction between -0.75 and -4.75 d in each eye. * astigmatism, if present, of not more than 1.50 d. * difference in ser between the two eyes (anisometropia) by manifest refraction not more than 1.00 d. * best corrected visual acuity in each eye equal to or better than +0.10 logmar (≥ 20/25 as snellen) * be in good general health based on his/her and parent's/guardian's knowledge. absence of ocular disease with full ophthalmic examination. without any ocular or systemic condition known to affect refractive status. * absence of strabismus by cover test at near or distance wearing correction. * absence of amblyopia * without ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. exclusion criteria: * vulnerability of subject * history of myopia control intervention * participation in any clinical study within 30 days of the baseline visit.

Keywords: refractive error eye disease
refinement and validation of a diagnostic model (gamad) for early detection of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: most hepatocellular carcinoma (hcc) cases were at advanced stage when diagnosis established. this study is intended to establish a clinical diagnostic model gamad for early-stage hcc and evaluate the diagnostic efficiency the same time. this study is a multicenter prospective study. participants including healthy control,hcc, liver cirrhosis, hepatitis and benign tumor-like lesions are consecutively recruited into the cohort. all the blood samples are collected before any treatments and will be tested in single center in order to decrease bias.

galad score including age, sex, pivka-ii(dcp), alpha-fetoprotein (afp) and alpha-fetoprotein l3 (afp-l3), is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. while increasing studies showed the diagnostic accuracy of afp-l3 was not as good as that of afp or pivka-ii, and afp-l3 was not significant in the multivariable model. thus, a model with better diagnostic accuracy and more suitable for chinese patients is needed. here, based on a multi-locus blood-based assay targeting circulating tumor dna methylation, we aim to develop a novel diagnostic model--gamad (gender, age, methylation, afp and dcp) and validate its performance among hcc patients and those at high risk of developing hcc,such as liver cirrhosis, hepatitis patients. this is a multicenter, observational, prospective study. after giving fully informed consent, the participants will undergo the regular treatment according to nccn guidelines.

Eligibility criteria:
inclusion criteria: * age above 18 * establishing diagnosis according to the european association for the study of liver(easl) criteria * high risk group of developing hcc including liver cirrhosis and hepatitis under the confirmed diagnosis * able to provide sufficient and qualified blood samples for study tests * no prior or undergoing cancer treatment (local or systematic) * able to provide a written informed consent exclusion criteria: * obstructive jaundice patients * medical history of taking warfarin * with other known malignant tumors or multiple primary tumors * patients with autoimmune diseases, genetic diseases, mental diseases/ disabilities and other diseases considered unsuitable for the study by the investigator * during pregnancy or lactation * recipient of blood transfusion within 3 months prior to study blood draw * insufficient qualified blood sample for study test

Keywords: early detection
aspirin dosing in diabetic patients

Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease

Summary: since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable cox-1 blockade of newly generated platelets. however, how different dosing regimens impact the pharmacodynamic effects of aspirin selectively in diabetes mellitus has been poorly explored. therefore, the aim of the present pilot investigation was to evaluate how increasing the frequency of aspirin administration, remaining within the daily recommended therapeutic doses, affects antiplatelet responsiveness in diabetic patients with coronary artery disease.


Eligibility criteria:
inclusion criteria: * medically treated (taking oral hypoglycemic medication and/or insulin) type 2 diabetes mellitus patients between 18 to 75 years with stable coronary artery disease exclusion criteria: * blood dyscrasia or bleeding diathesis * oral anticoagulation therapy with a coumadin derivative * recent antiplatelet treatment (\< 30 days) with a glycoprotein iib/iiia antagonist, thienopyridine (ticlopidine, clopidogrel), cilostazol or dipyridamole platelet count \< 100 /microl * history of gastrointestinal bleed within last 6 months * history of cerebrovascular accident within last 3 months * history of hospitalization for an acute coronary event or coronary revascularization (percutaneous or surgical) in the past 12 months * active bleeding or hemodynamic instability * any active malignancy * serum creatinine \> 2 mg/dl * baseline alt \> 2.5 times the upper limit of normal * pregnant females * hba1c \> 10% * use of nonsteroidal anti-inflammatory drugs past 10 days.

Keywords: diabetes mellitus, coronary artery disease, aspirin therapy
radiotherapy dose de-escalation in hpv-associated cancers of the oropharynx

Conditions: Oropharynx Cancer

Summary: the purpose of this study is to use intra-treatment 18fdg-pet/ct during definitive radiation therapy for human papillomavirus (hpv)-related oropharyngeal cancer (opc) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. this study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.


Eligibility criteria:
inclusion criteria: * histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive hpv in situ hybridization (ish) and/or positive hpv pcr * stage i-iii (ajcc 8th edition) with plan for concurrent chemotherapy per standard of care treatment * zubrod/ecog score of 0-1 * weight loss \<10% in the 3 months prior to diagnosis * ≥ 18 years of age * no prior chemotherapy for their current cancer diagnosis exclusion criteria: * prior radiotherapy to the head and neck * medical contraindications to radiation therapy * absence of gross disease on imaging prior to beginning radiation therapy * distant metastatic disease * medical contraindication to pet/ct * history of active cancer other than non-melanoma skin cancer within the last 5 years

Keywords: pet-ct
incidence and severity of silent and apparent cerebral embolism after conventional and minimal-invasive transfemoral aortic valve replacement

Conditions: Cerebral Stroke; Aortic Valve Disease

Summary: the purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.

patients undergoing aortic valve repair (avr) are included prospectively into the study. avr techniques include the conventional technique, the transfemoral and the transapical approach. before the intervention ct of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. patients undergo mri of the brain, including diffusion weighted imaging (dwi) and neurological assessment (nihss score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.

Eligibility criteria:
inclusion criteria: * aortic valve replacement exclusion criteria: * contraindication to undergo mri